FDA 510(k) Application Details - K963276

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K963276
Device Name Thermometer, Electronic, Clinical
Applicant SAFETY 1ST, INC.
210 BOYLSTON ST.
CHESTNUT HILL, MA 02167 US
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Contact PAUL A WARE
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 08/20/1996
Decision Date 12/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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